Biocon Ltd, India's largest biotechnology firm, has made a paradigm shift from being a generic drug manufacturer to innovation to drive its future growth aggressively. //
"We are rapidly transforming from a generics API (active pharmaceutical ingredients) manufacturer into an innovator for developing a robust pipeline of new molecules.
"We believe this strategy will deliver strong and sustainable growth in the future," Biocon chairperson Kiran Mazumdar-Shaw told reporters here Thursday.
Giving the company's outlook for the current fiscal (2006-07), Shaw said the year ahead would continue to be challenging due to uncertainties in market conditions and the impact of depreciation at its new facilities in the biotech park.
"We believe our balanced portfolio of products and services will deliver superior shareholder value over the medium and long-term. We expect our insulin products to gain substantial market share both in India and overseas markets," Shaw said.
The company, however, did not give any revenue guidance figure for the current fiscal or its first quarter (April-June) of FY 2007 as the biotech sector is evaluated on a medium to long-term basis, given the gestational nature of its R&D investments and regulatory time lines.
According to Biocon chief operating officer (COO) Arun Chandavarkar, the company's innovation strategy was built on in-house capabilities, proprietary technologies and a broad array of licensing and alliance partners the world over.
"Our focus on IP (intellectual property) and technology continues to be a strong differentiator. We have invested Rs.760 million in R&D capabilities during fiscal 2005-06, which is an increase of 76 percent over the previous fiscal (2004-05)," Chandavarkar said.
On the acquisition of the US-based Nobex portfolio for $5 million, Shaw said the company would leverage the proprietary intellectual (IP) assets through a combination of in-ho
use development, licensing and co-development.
The strategic acquisition gives Biocon access to about 300 granted or filed patents of Nobex in oral peptide delivery in the metabolic and cardiovascular segment.
"Besides full ownership of oral insulin and oral BNP programmes, we will have access to products in early phase I & II development such as oral calcitonin, oral para thyroid hormone (PTH) and Apaza, an oral small molecule for inflammatory bowel diseases," Shaw pointed out.
As part of its long-term strategy, the company plans to build bio-similar therapeutic protein franchise through in-house development and strategic collaborations.
With the commissioning of the multi-product biologics facility (Biopharmaceuticals) this month in its Biotech Park, the company is gearing up to manufacture a range of monoclonal anti-bodies and other recombinant therapeutic products.
"We have completed registration enabling clinical trials for our therapeutic drug (BIOMAb EGFR) to treat neck and head cancers.
Investigational new drug application (IND) for diabetes oral insulin is on track for filing later this year," Chandavakar added.
Meanwhile, the company has entered into an agreement with the Sweden-based Karolinska Institute to partner in product development, joint research programmes and scientific symposia in India.
During the fiscal year 2005-06, Biocon posted a consolidated income of Rs.7.93 billion and net profit of Rs.1.74 billion.
As part of its capital expenditure, Biocon invested Rs.6.5 billion over the last two years in expanding its existing capacities and setting up new manufacturing facilities for its two subsidiaries - Clinigene and Syngene.
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